Supportive Care Intervention-Pancreas

NCT ID: NCT01885884

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-08-31

Brief Summary

This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.

Conditions

Advanced Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care Intervention

Monthly (minimum) patient \& caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).

Group Type: EXPERIMENTAL

Embedded Supportive Care

Intervention Type: BEHAVIORAL

Usual Care

Participants will receive standard oncology care from their oncology providers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Embedded Supportive Care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients:

• Adults (≥ 18 years old)
• Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
• Planning to receive continued care from an oncologist at the Hillman Cancer Center
• Accompanied by a caregiver (family member or friend) at the first visit
• Caregivers:

• Adults (>= 18 years old)
• Family member or friend of an eligible patient

Exclusion Criteria

• Patients:

• Unable to read and respond to questions in English
• Not planning to receive continued care from an oncologist at the Hillman Cancer Center
• Pancreatic neuroendocrine cancer
• Caregivers:

• Unable to read and respond to questions in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Yael Schenker, MD, MAS

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yael Schenker, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO13020507

Identifier Type: -

Identifier Source: org_study_id